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U.S. Department of Health and Human Services

Class 2 Device Recall Lap Appy TraceCart

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  Class 2 Device Recall Lap Appy TraceCart see related information
Date Initiated by Firm October 01, 2008
Date Posted November 07, 2008
Recall Status1 Terminated 3 on December 02, 2009
Recall Number Z-0197-2009
Recall Event ID 49553
Product Classification Custom surgical kit - Product Code KDD
Product DeRoyal Lap Appy TraceCart, REF53-1776, Rx only, non-sterile. (custom surgical kit)
Code Information Lot numbers: 13819779, 14002496, and 14356032
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information Contact Mr. Tracy Edmundson
865-362-2334
Manufacturer Reason
for Recall		 Surgical kits contained a recalled Endopath ETX 35 mm Endoscopic Linear Cutter White Reload/Cartridges.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm sent out recall notices to their sales representatives, the distributors, and the hospitals addressed to the Recall Coordinator/OR Supervisor on 10/2/08. These notices stated that the recalling firm's sales representatives would perform the field correction in lieu of returning the kits. Contact DeRoyal Industries, Inc. at 1-865-362-6157 for assistance.
Quantity in Commerce 4 kits
Distribution LA & KY
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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